(70 days)
No
The summary describes a mechanical bone anchor system with minor design changes and a force-measuring spring. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for the treatment of stress type (female) urinary incontinence."
No
The device is described as a system for soft tissue fixation using bone anchors for the treatment of urinary incontinence, which indicates a therapeutic or surgical function rather than a diagnostic one.
No
The device description clearly outlines physical components: a bone anchor and a bone anchor inserter, made of materials like stainless steel. It also describes mechanical features like a force measuring spring. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue fixation to the pubic bone by means of bone anchors threaded with suture" for the treatment of stress urinary incontinence. This is a surgical procedure involving the implantation of a device, not a test performed on biological samples outside the body to diagnose a condition.
- Device Description: The device consists of a bone anchor and an inserter. These are physical components used in a surgical procedure.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing process.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The In-Tac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes
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Device Description
Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System consists of two components: a bone anchor, and a bone anchor inserter The In-Tac Bone Anchor System has the same overall design and technological characteristics as the configuration cleared under K962372, but implements the following changes: (1) the sutures will be provided pre-threaded for user convenience, and the retractable anchor shield will be incorporated into the disposable anchor assembly; (2) the inserter will be made from a stronger grade of stainless steel; and (3) the inserter incorporates a force measuring spring to ensure the anchors are deployed only if sufficient insertion force is applied.
All materials used in the In-Tac Bone Anchor System are commonly used in medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pubic bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing demonstrated that the materials are biocompatible. Bench testing demonstrated that the modifications made to the UroTac Bone Anchor System had no effect on device safety and effectiveness, and that its performance is substantially equivalent to the 510(K)cleared configuration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
1964953
Summary of Safety and Effectiveness Influence, Inc.'s In-Tac Bone Anchor System FEB 1 3 1997 510(k) Number 1964953
This 510(k) notification is submitted by Influence, Inc., 601 Montgomery Street, Suite 845, San Francisco, California 94111. The contact person is Peter A. Bick, President and CEO.
This 510(k) notification addresses modifications to the Influence, Inc. UroTac Bone Anchor System, a staple driver (21 CFR 888.4540) cleared under K962372. The modified device will be called the In-Tac Bone Anchor System. The modifications have been implemented to improve convenience of device use, and to provide enhanced material strength. In addition, the labeling has been modified to incorporate the indication for stress urinary incontinence resulting from intrinsic sphincter deficiency, and to provide instructions for use of the device in transvaginal sling procedures.
Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The In-Tac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System consists of two components: a bone anchor, and a bone anchor inserter The In-Tac Bone Anchor System has the same overall design and technological characteristics as the configuration cleared under K962372, but implements the following changes: (1) the sutures will be provided pre-threaded for user convenience, and the retractable anchor shield will be incorporated into the disposable anchor assembly; (2) the inserter will be made from a stronger grade of stainless steel; and (3) the inserter incorporates a force measuring spring to ensure the anchors are deployed only if sufficient insertion force is applied.
All materials used in the In-Tac Bone Anchor System are commonly used in medical devices. Biocompatibility testing demonstrated that the materials are biocompatible. Bench testing demonstrated that the modifications made to the UroTac Bone Anchor System had no effect on device safety and effectiveness, and that its performance is substantially equivalent to the 510(K)cleared configuration.
Based on the information provided, the In-Tac Bone Anchor System is substantially equivalent to the UroTac Bone Anchor System with respect to intended use, technological characteristics, and performance.
510(k) Notification for the In-Tac Bone Anchor System Page 46